Warning(s)

REMS:

FDA approved a REMS for sacrosidase to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Administer initial doses near a facility where adequate treatment for acute hypersensitivity reactions can be obtained.124 Alternatively, perform skin testing to assess presence of hypersensitivity to sacrosidase.13

General Precautions

Dietary Restriction of Starch

Sacrosidase does not provide replacement for isomaltase deficiency; restriction of dietary starch may be necessary to achieve greatest reduction in symptoms.124 Evaluate each patient treated to determine need for restriction of dietary starch.12

Acquired Disaccharidase Deficiencies

Not evaluated in patients with secondary (acquired) disaccharidase deficiencies.12